The Role of KL-6 in the Clinical Diagnosis of ILD

Completed

• Conditions: Interstitial Lung Disease

• Registration Number: NCT02197364
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Brief Summary

The purpose of the study is to evaluate the significance of KL-6 as a biomarker in the clinical diagnosis of interstitial lung disease (ILD) by detecting serum KL-6 levels among patients with ILD, and comparing them to the clinical diagnostic criteria and other respiratory diseases. In addition, the study discusses the value of KL-6 levels in terms of ILD treatment effect evaluation through the detection of serum KL-6 levels before treatment and after treatment.

Detailed Description

As a multi-center, double-blind clinical study, the trial is divided into two parts.

Part 1: The purpose of this part is to evaluate the role of KL-6 as a biomarker in the clinical diagnosis of interstitial lung disease (ILD) by detecting serum KL-6 levels among patients with ILD, and comparing them to the clinical diagnostic criteria and other respiratory diseases, including pulmonary tuberculosis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease and healthy control group.

Part 2: The purpose of this part is to study the value of KL-6 levels in terms of ILD treatment effect evaluation through the detection of serum KL-6 levels before treatment and 30-90 days after treatment. Treatment includes anti fibrosis, anti-inflammatory and other conventional therapies.

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2014-04
• Study Completion: 2014-05
• Status Verified: 2014-07
• Study First Submitted: 2014-07-16
• Study First Submitted QC: 2014-07-18
• Last Update Submitted: 2014-07-18
• Study First Posted: 2014-07-22
• Last Update Posted: 2014-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1190

Inclusion Criteria

• Serums from patients with ILD, pulmonary tuberculosis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease and health
• Serums from patients with ILD: before treatment and 30-90 days after treatment

Exclusion Criteria

• Serums from patients with cancer
• Serums with visible precipitate
• Serums with floc

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The KL-6 concentration on the immune analyzer	The serum from patients with ILD will be collected for the duration of hospital stay, an average of 4 weeks	Detect the KL-6 concentration in serum by the use of the immune analyzer among patients with ILD.

Secondary Outcome Measures

Name	Time	Method
The KL-6 concentration on the immune analyzer	The serum from healthy people will be collected for the duration of physical examination, an average of 1 day	Detect the KL-6 concentration in serum by the use of the immune analyzer among healthy people.
Change of KL-6 concentration on the immune analyzer	pretherapy, 30-90 days after treatment	Change of KL-6 concentration on the immune analyzer from pretherapy to 30-90 days after treatment among patients with ILD.